Humate-P

Humate-P [antihemophilic factor/von Willebrand factor complex (human)] is an Antihemophilic Factor/von Willebrand Factor (VWF) Complex (Human) indicated for treatment and prevention of bleeding in adults with hemophilia A; and to treat spontaneous and trauma-induced bleeding episodes, and to prevent excessive bleeding during and after surgery in adults and pediatric patients with von Willebrand disease (VWD). This applies to patients with severe VWD as well as patients with mild to moderate VWD where the use of desmospressin is known or suspected to be inadequate. Common side effects of Humate-P include:

• allergic-anaphylactic reactions:
• hives,
• chest tightness,
• rash,
• itching,
• swelling,)
• Patients undergoing surgery:
• postoperative wound and injection-site bleeding, and
• nosebleed

The dose of Humate-P to treat hemophilia A is one International Unit (IU) of factor VIII (FVIII) activity per kg body weight that increases the circulating FVIII level by approximately 2.0 IU/dL. Dosage is individualized based on the patient's weight, type and severity of hemorrhage, FVIII level, and presence of inhibitors. The dose of Humate-P to bleeding episodes in von Willebrand disease is 40-80 IU VWF:Ristocetin Cofactor (RCo) per kg body weight every 8-12 hours. Humate-P may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Humate-P; it is unknown how it would affect a fetus. It is unknown if Humate-P passes into breast milk. Consult your doctor before breastfeeding.

Our Humate-P [antihemophilic factor/von Willebrand factor complex (human)] Lyophilized Powder for Reconstitution for Intravenous Use Only Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Humate-P Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; chest tightness, wheezing, difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• hot flashes when the injection is given;
• sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance;
• sudden cough, coughing up blood;
• pain, swelling, warmth, or redness in one or both legs;
• pale or yellowed skin, dark colored urine, fever, confusion or weakness;
• bleeding from a wound or where the medicine was injected; or
• bleeding that is not controlled.

Common side effects may include:

• nosebleeds;
• rash or itching;
• numbness or tingling;
• headache, dizziness; or
• back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Humate-P (Antihemophilic Factor/von Willebrand Factor Complex (Human) Injection)

 

Humate-P Professional Information

SIDE EFFECTS

The most serious adverse reaction observed in patients receiving Humate-P is anaphylaxis. Thromboembolic events have also been observed in patients receiving Humate-P for the treatment of VWD [see WARNINGS AND PRECAUTIONS]. Reports of thromboembolic events in VWD patients with other thrombotic risk factors receiving coagulation factor replacement therapy have been obtained from spontaneous reports, published literature, and a European clinical study. In some cases, inhibitors to coagulation factors may occur. However, no inhibitor formation was observed in any of the clinical studies.

In patients receiving Humate-P in clinical studies for treatment of VWD, the most commonly reported adverse reactions observed by >5% of subjects are allergic-anaphylactic reactions (including urticaria, chest tightness, rash, pruritus, and edema). For patients undergoing surgery, the most common adverse reactions are postoperative wound and injection-site bleeding, and epistaxis.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice.

Treatment Of Bleeding Episodes In VWD

Allergic symptoms, including allergic reaction, urticaria, chest tightness, rash, pruritus, and edema, were reported in 6 of 97 (6%) subjects in a Canadian retrospective study [see Clinical Studies]. Four of 97 (4%) subjects experienced seven adverse events that were considered to have a possible or probable relationship to Humate-P. These included chills, phlebitis, vasodilation, paresthesia, pruritus, rash, and urticaria. All were mild in intensity with the exception of a moderate case of pruritus.

In a prospective, open-label safety and efficacy study of Humate-P in VWD subjects with serious life- or limb-threatening bleeding or undergoing emergency surgery, seven of 71 (10%) subjects experienced nine adverse reactions. These were one occurrence each of mild vasodilation and mild pruritis; two occurrences of mild paresthesia; and one occurrence each of moderate peripheral edema and extremity pain and severe pseudothrombocytopenia (platelet clumping with a false low reading). Humate-P was discontinued in the subject who experienced the peripheral edema and extremity pain.

Prevention Of Excessive Bleeding During And After Surgery In VWD

Among the 63 VWD subjects who received Humate-P for prevention of excessive bleeding during and after surgery, including one subject who underwent colonoscopy without the planned polypectomy, the most common adverse events were postoperative hemorrhage (35 events in 19 subjects with five subjects experiencing bleeding at up to three different sites), postoperative nausea (15 subjects), and postoperative pain (11 subjects). Table 5 presents the postoperative hemorrhagic adverse events.

Table 5: Hemorrhagic Adverse Events in 63 Surgical Subjects

Adverse Event	Surgical Procedure Category	Number of Subjects/ Events	Onset* (Number of Events)		Severity (Number of Events)
			On	Post	Mild	Mod	Severe
Wound/injection site bleeding	Major	8/11	7	4	9	-	2
	Minor	2/2	2	-	1	1	-
	Oral	2/6	-	6	3	3	-
Epistaxis	Major	4/4	2	2	3	1	-
	Minor	1/1	1	-	1	-	-
Cerebral hemorrhage/ subdural hematoma	Major	½	2†	-	-	2	-
Gastrointestinal bleeding	Major	1/3	3‡	-	-	2	1
Menorrhagia	Major	1/1	1§	-	-	1	-
Groin bleed	Oral	1/1	-	1	1	-	-
Ear bleed	Major	1/1	1	-	1	-	-
Hemoptysis	Major	1/1	1	-	1	-	-
Hematuria	Major	1/1	1	-	1	-	-
Shoulder bleed	Major	1/1	1	-	1	-	-
* On = on-therapy; onset while receiving Humate-P or within 1 day of completing Humate-P administration. Post = post-therapy; onset at least one day after completing Humate-P administration. † Reported as serious adverse events following intracranial surgery. ‡ Two of these events were reported as serious adverse events following gastrojejunal bypass. § Reported as a serious adverse event requiring hysterectomy following hysteroscopy and dilation and curettage.

Table 6 lists the non-hemorrhagic adverse events reported in at least two subjects, regardless of causality, and the adverse events that were possibly related to Humate-P. Pulmonary embolus considered possibly related to Humate-P occurred in one elderly subject who underwent bilateral knee replacement.

Table 6: Non-Hemorrhagic and Possibly Related Adverse Events in 63 Surgical Subjects

Body System	Adverse Event (AE)	Number of Subjects With an AE Possibly Related to Humate-P	Number of Subjects With an AE Regardless of Causality*
Body as a whole	Pain	-	11
	Fever	-	4
	Abdominal pain	-	3
	Infection	-	3
	Surgery	-	3
	Back pain	-	2
	Facial edema	-	2
Cardiovascular	Chest pain	-	3
	Pulmonary embolust	1	1
	Thrombophlebitis†	1	1
Digestive	Nausea	1	15
	Constipation	-	7
	Vomiting	1	3
	Sore throat	-	2
Hemic and lymphatic system	Anemia/decreased hemoglobin	-	2
Metabolic/ nutritional	Increased SGPT	1	1
Nervous	Dizziness	1	5
	Headache	1	4
	Increased sweating	-	3
	Insomnia	-	2
Skin and appendages	Pruritus	-	3
	Rash	1	1
Urogenital	Urinary retention	-	4
	Urinary tract infection	-	2
* Events occurring in two or more subjects. † Events occurring in separate subjects.

Eight subjects experienced 10 postoperative serious adverse events: one with subdural hematoma and intracerebral bleeding following intracranial surgery related to an underlying cerebrovascular abnormality; one with two occurrences of gastrointestinal bleeding following gastrojejunal bypass; and one each with sepsis, facial edema, infection, menorrhagia requiring hysterectomy following hysteroscopy and dilation and curettage, pyelonephritis, and pulmonary embolus.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Humate-P. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Humate-P exposure.

Adverse reactions reported in patients receiving Humate-P for treatment of VWD or hemophilia A are allergic-anaphylactic reactions (including urticaria, chest tightness, rash, pruritus, edema, and shock), development of inhibitors to FVIII, and hemolysis. Additional adverse reactions reported for VWD are thromboembolic complications, chills and fever, and hypervolemia.

Read the entire FDA prescribing information for Humate-P (Antihemophilic Factor/von Willebrand Factor Complex (Human) Injection)